Manuel Albornoz Cabello
Seville, Spain
NCT Number: NCT04483128
The aim of this study it's to analyze the relationship between autonomic nervous system balance (ANSb) and chronic pain conditions, especially in this case, non-especific chronic low back pain (CLBP).
Most of physiotherapy approaches focus only in biomechanical aspects, leaving aside what kind of factors could perpetuate CLBP. Since 1985, ANSb was studied due to its potential contribution to chronic pain.
Electrical stimulation, through interferential currents (IFC), it's a safe and well-known therapy used in CLBP with good outcomes regarding pain relief.
The main objective of this study it's to quantify the association between CLBP and ANSb alterations. In second place, the research team aims to record the influence of IFC over pain and ANSb in those subjects.
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Notify Me18 year–65 year
Male
Interventional
Not applicable
Seville, Spain
In the first place, a meeting will be organized with the patients to resolve any doubt about the study and its process. The investigators will make sure every instruction is understandable, giving enough time to read and ask pertinent questions.
Secondly, patients will be provided of an informed consent specific for the present study, according to the legal forms. Participants must agree with all the information and sign the document.
At this point, patients will be interviewed individually by a researcher to collect all the data regarding to the Clinical History in Physiotherapy.
In the next step, patients will be randomized into two different groups by choosing one opaque envelope, containing a number for the allocation. A researcher will make the final allocation depending on the number. Patients were unaware of the group allocation for masking.
This study has to possible groups with a common indication for both:
Before and after the session, all the variable measurements will be collected in the same environmental conditions by the same researcher. Basal measurement (before intervention) will be recorded 15 minutes before session for 10 minutes. The second measurement will be taken while the patient recieves the intervention for 20 minutes.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Application of IFC with Sonopuls 692® (Enraf-Nonius BV, Rotterdam, The Netherlands) device. Parameters:
Application of IFC with Sonopuls 692® (Enraf-Nonius BV, Rotterdam, The Netherlands) device. Parameters:
Time frame: Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.
Heart Rate variability (HRV) is measured by calculating mean HR, maximum HR and minimum HR. First Beat Bodyguard2 device will be used to collect HRV.
Time frame: Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.
Heart Rate variability (HRV) is measured by calculating mean HR, maximum HR and minimum HR. First Beat Bodyguard2 device will be used to collect HRV.
Time frame: Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.
RMSSD it's an indirect indicator of parasympathic nervous system level of activity. First Beat Bodyguard2 device will be used to collect RMSSD.
Time frame: Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.
RMSSD it's an indirect indicator of parasympathic nervous system level of activity. First Beat Bodyguard2 device will be used to collect RMSSD.
Time frame: Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.
SD1 is an indicator of the autonomic nervous balance. First Beat Bodyguard2 device will be used to collect it.
Time frame: Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.
SD1 is an indicator of the autonomic nervous balance. First Beat Bodyguard2 device will be used to collect it.
Time frame: Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.
SD2 is an indicator of the autonomic nervous balance. First Beat Bodyguard2 device will be used to collect it.
Time frame: Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.s.
SD2 is an indicator of the autonomic nervous balance. First Beat Bodyguard2 device will be used to collect it.
Time frame: Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.
SS it's an indicator of sympathetic nervous system level of activation. First Beat Bodyguard2 device will be used to collect SS.
Time frame: Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.s.
SS it's an indicator of sympathetic nervous system level of activation. First Beat Bodyguard2 device will be used to collect SS.
Time frame: Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.
S/PS Ratio it's an indicator of autonomic nervous system balance. First Beat Bodyguard2 device will be used to collect S/PS Ratio.
Time frame: Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.s.
S/PS Ratio it's an indicator of autonomic nervous system balance. First Beat Bodyguard2 device will be used to collect S/PS Ratio.
Time frame: Evaluation before intervention (basal): 15 minutes before intervention.
NPRS it's an scale used to measure with ease, patient's perceived pain with a scoring of 0 (no pain) and 10 (maximum pain).
Time frame: Evaluation immediately after treatment session.
NPRS it's an scale used to measure with ease, patient's perceived pain with a scoring of 0 (no pain) and 10 (maximum pain).
Time frame: Evaluation before intervention (basal): 15 minutes before intervention.
RMQ it's a questionnaire used to measure an individual level of disability related to low back pain, with a scoring of 0 (no disability at all) and 24 (maximum disability).
Time frame: Evaluation immediately after treatment session.
RMQ it's a questionnaire used to measure an individual level of disability related to low back pain, with a scoring of 0 (no disability at all) and 24 (maximum disability).
Time frame: Evaluation before intervention (basal): 15 minutes before intervention.
SPPA it's a questionnaire made to measure subject's susceptibility to receive electrical stimulation. A scoring of >45 points indicates that subject shouldnt be treated with electrical therapy.
Time frame: Recorded immediately after treatment session.
Maximal dosimetry reached during the session will be recorded in mA.
University of Seville
Other
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